Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension
NCT ID: NCT06152861
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
250 participants
INTERVENTIONAL
2023-11-15
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Travoprost Ophthalmic Topical Cream low-dose
Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days
Travoprost Ophthalmic Topical Cream low-dose
travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes
Travoprost Ophthalmic Topical Cream mid-dose
Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days
Travoprost Ophthalmic Topical Cream mid-dose
travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes
Travoprost Ophthalmic Topical Cream high-dose
Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days
Travoprost Ophthalmic Topical Cream high-dose
travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes
Timolol maleate ophthalmic solution, 0.5%
Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days
Timolol maleate ophthalmic solution, 0.5%
timolol maleate ophthalmic solution, 0.5% twice daily (morning \& evening) to both eyes
Travoprost ophthalmic solution, 0.004%
Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days
Travoprost Ophthalmic Solution, 0.004%
travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Travoprost Ophthalmic Topical Cream low-dose
travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes
Travoprost Ophthalmic Topical Cream mid-dose
travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes
Travoprost Ophthalmic Topical Cream high-dose
travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes
Timolol maleate ophthalmic solution, 0.5%
timolol maleate ophthalmic solution, 0.5% twice daily (morning \& evening) to both eyes
Travoprost Ophthalmic Solution, 0.004%
travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;
* Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;
* Qualifying IOP in the study eye;
* Best-corrected visual acuity of approximately 20/80 Snellen in each eye
Exclusion Criteria
* Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;
* History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;
* History of cerebrovascular insufficiency;
* Any form of glaucoma other than open-angle glaucoma
* Advanced visual field loss or cup-to-disc ratio of 0.8 or greater
* Non-qualifying prior surgeries or procedures in either eye
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Glaukos Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Glaukos Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Glaukos Clinical Study Site
Newport Beach, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Glaukos Study Manager
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GLK-311-01
Identifier Type: -
Identifier Source: org_study_id